Cleared Traditional

K261275 - Unity Total Knee System, Unity Knee Cementless CR Femur

K261275 is an FDA 510(k) clearance for Unity Total Knee System, manufactured by Corin, Ltd.. The device is a Class 2 Orthopedic device with product code MBH cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K261275 · Corin, Ltd. · Orthopedic device
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Sep 2026
Decision
153d
Days
Class 2
Risk

K261275 is an FDA 510(k) clearance for the Unity Total Knee System, Unity Knee Cementless CR Femur. Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (product code MBH), Class II - Special Controls.

Submitted by Corin, Ltd. (Cirencester, GB). The FDA issued a Cleared decision on September 17, 2026 after a review of 153 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3565 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Corin, Ltd. devices

FDA 510(k) Submission Details - K261275

510(k) Number K261275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2026
Decision Date September 17, 2026
Days to Decision 153 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 122d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBH Device Classification - Class 2, Special Controls

Product Code MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3565
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

All 145
Devices cleared under the same product code (MBH) and FDA review panel - the closest regulatory comparables to K261275.
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K253328 · Medacta International S.A. · Feb 2026
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